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New Research Compliance Issues for Biological and Hazardous Materials. Peter A. Reinhardt, Director Dept. of Environment, Health & Safety. Overview of Today. Shipment/mailing of research materials, sample and specimens Department of Commerce Export rules Select Agent requirements

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New research compliance issues for biological and hazardous materials

New Research Compliance Issues for Biological and Hazardous Materials

Peter A. Reinhardt, Director

Dept. of Environment, Health & Safety

Overview of today

2 March 2005 Materials

Overview of Today

  • Shipment/mailing of research materials, sample and specimens

  • Department of Commerce Export rules

  • Select Agent requirements

  • “Dual Use” concerns for biological research

  • Institutional controls

Themes for today why are these changes taking place

2 March 2005 Materials

Themes for TodayWhy are these changes taking place?

  • Prevent risks to the public from research activities and materials

  • Address “Dual Use” concerns: Research activities and materials used for social good have the potential to be used for social harm.

  • Internal and external controls to prevent access to dual use materials, technology and information by those who wish us harm.

Shipping mailing research materials

2 March 2005 Materials

Shipping/Mailing Research Materials

“Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $27,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison.”

Laws for the transport of hazardous material

2 March 2005 Materials

Laws for the Transport of Hazardous Material...

  • U.S. Department of transportation (DOT): title 49 of the code of federal regulations (CFR)

  • For air transport:

    • International civil aviation organization (ICAO) technical instructions

    • International air transport association (IATA) dangerous goods regulations

Preparing hazardous materials for shipment

2 March 2005 Materials

Preparing Hazardous Materials for Shipment...

If you prepare or package a shipment, you must receive additional function-specific training in:

  • Approved packaging materials and procedures

  • Labeling packages

  • Marking packages

  • Preparing shipping papers

  • Emergencies response contact information

No vial in pocket

2 March 2005 Materials

No Vial In Pocket

New research compliance issues for biological and hazardous materials

Monday, September 13, 2004 Materials

Professor at U. of Delaware Pleads Guilty in Case Involving Smuggled Poultry Virus

A popular professor of microbiology at the University of Delaware pleaded guilty last week to criminal charges related to the smuggling of a poultry virus from Saudi Arabia.

If the federal judge presiding over the case accepts a plea agreement reached with the U.S. attorney for Maine, the professor, John K.

Rosenberger, will serve six months of home detention, be on probation for two years, and pay a fine of up to $250,000.

Mr. Rosenberger, a former chairman

of the department of animal and food sciences at Delaware's College of Agriculture and Resources, is known for his work on avian disease. He pleaded guilty in the U.S. District Court in Bangor, Me., to aiding and abetting the receipt and concealment of a smuggled virus -- in this case, a type of avian influenza that can devastate commercial flocks -- in his university laboratory.

George T. Dilworth, an assistant U.S. attorney in Maine, said there are no bioterrorism connections in the case. However, he said, before the September 11 terrorist attacks, people were too cavalier about violating regulations on the importing of viruses from other countries. "We now understand why these rules are as strict as they are," he said.

U s export control laws

2 March 2005 Materials

U.S. Export Control Laws

Regulate the distribution to foreign nationals and foreign countries of strategically important products, services and information for reasons of foreign policy and national security

Credits: Erica Kropp and Anne Bowden, University of Maryland College Park

Robert Hardy, Council on Government Relations

U s export control laws and agencies

2 March 2005 Materials

U.S. Export Control Laws and Agencies

Implications of export laws

2 March 2005 Materials

Implications of Export Laws

  • No effect on 90% of university research

  • Impact on:

    • Ability of foreign students to participate in research involving a controlled technology (mostly under ITAR)

    • Ability to provide services (e.g., training) involving controlled equipment to foreign nationals (ITAR, EAR, OFAC)

    • Ability to send controlled equipment to foreign countries (ITAR, EAR, and OFAC)

Itar licensing requirements for shipping controlled equipment out of the u s

2 March 2005 Materials

ITAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S.

  • A license is required to ship equipment controlled by ITAR to any foreign country

  • There are few exclusions or exceptions

  • It can take months to obtain a license from the State Department

Ear licensing requirements for shipping controlled equipment out of the u s

2 March 2005 Materials

EAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S.

  • A license may be required to ship materials, samples or equipment out of the U.S. under the EAR depending on whether the equipment is controlled, where it is being sent and whether an exception applies.

  • A license may be required to ship software out of the US!

  • The process to classify equipment under the EAR is very tedious, detailed and time consuming.

Ofac prohibitions for shipping controlled equipment out of the u s

2 March 2005 Materials

OFAC Prohibitions for Shipping Controlled Equipment Out of the U.S.

  • There is a presumption under OFAC laws that any and all shipments of materials, equipment and provision of services to countries subject to US sanctions/boycotts or persons in those countries are ILLEGAL.

  • Balkans, Burma, Cuba, Iran, Iraq, Libya, Liberia, Sudan, Syria, Zimbabwe

Fundamental research exclusion

2 March 2005 Materials

Fundamental Research Exclusion

Applies to information resulting from basic and applied research in science and engineering conducted at an accredited institution of higher education (EAR) or higher learning (ITAR) located in the U.S. that is not restricted for proprietary reasons or specific national security reasons (EAR) or subject to specific U.S.G. access and dissemination controls (ITAR) See 15 CFR 734.8(a) and 22 CFR 120.11(a)(8).

Ear fundamental research exclusion

2 March 2005 Materials

EAR Fundamental Research Exclusion

  • No license is required to disclose to foreign nationals information which is “published and which is generally accessible or available to the public [through, for example] fundamental research in science and engineering at universities where the resulting information is ordinarily published and shared broadly in the scientific community.”

Ear fundamental research exclusion continued

2 March 2005 Materials

EAR Fundamental Research Exclusion, continued.

  • Also note EAR 734.3(b)(3)(ii) exemption for “publicly available technology” that “arise(s) during or result(s) from fundamental research.”

Shipment of controlled materials, samples or other commodities outside of the U.S. is never excluded.

The deemed export concept

2 March 2005 Materials

The “Deemed Export” Concept

  • Defined as the transfer or disclosure (including visually or orally) of controlled “technologies” (EAR) or “technical data” (ITAR) to a foreign entity or individual anywhere including in the U.S. See 15 CFR 734.2 and 22 CFR 120.17.

  • Technology is specific information necessary for the “development,” “production” or ”use” of a product (EAR 772.1)

The deemed export concept1

2 March 2005 Materials

The “Deemed Export” Concept

  • Technical data is information required for design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of controlled articles (ITAR 120.10).

  • The concept of “deemed export” was added to export regulations in 1994. The intent apparently was to cover information needed for commercial development, production and use of technologies.

Ear regulated research on campus
EAR Materials Regulated Research On Campus

2 March 2005

= “Deemed Export”

Ear fundamental research exclusion is destroyed if the university accepts any contract clause that

2 March 2005 Materials

EAR Fundamental Research ExclusionIs destroyed if the University accepts any contract clause that:

  • Forbids the participation of foreign nationals;

  • Gives the sponsor a right to approve publications resulting from the research; or

  • Otherwise operates to restrict participation in research and/or access to and disclosure of research results

Red flags for export control laws

2 March 2005 Materials

Red Flags for Export Control Laws

  • The RFP marked “Export Controlled”

  • Working with a country subject to a U.S. boycott

  • Shipping equipment to a foreign country

  • Collaborating with foreign colleagues in foreign countries

  • Sponsor demands pre-approval rights over publications or the participation of foreign national students

  • Training foreign nationals in using equipment

If export control red flags exit

2 March 2005 Materials

If Export Control Red Flags Exit

  • Determine if the research activity is allowed.

  • Determine if an export control license is required.

  • If license is needed, it takes much time and effort of faculty. It can take months to process.

  • The license may be denied.

  • These laws apply to all research activities—not just sponsored projects

Ear penalties

2 March 2005 Materials

EAR Penalties

  • Civil violations

    • Up to $12k per violation for individuals and the University/corporations

  • Criminal violations (willful)

    • Up to $1 million for the University

    • Up to $250K per violation for individuals and/or up to 10 years in prison

Trouble on the horizon

2 March 2005 Materials

Trouble on the Horizon

In March 2004, the Department of Commerce’s Inspector General issued a report on the status of EAR compliance, and stated that: “Technology related to controlled equipment—regardless of how use is defined—is subject to the deemed export provisions (and the requirement to license foreign nationals having access to that equipment) even if the research being conducted with that equipment is fundamental.”

2002 public health security and bioterrorism preparedness and response act

2 March 2005 Materials

2002 Public Health Security and Bioterrorism Preparedness and Response Act

  • 12 June 2002: Signed into law

  • August 2002: Notification of possession (not just transfers) of all select agents and toxins

  • 13 December 2002: New 42 CFR 73 Rules (replacing Part 72) promulgated as Interim Final

  • 7 February-11 November: 42 CFR 73 implementation

Examples of regulated select agents

HHS-USDA Overlap Materials

Bacillus anthracis

Botulinum neurotoxin producing species of Clostridium

Francisella tularensis

Venezuelan Equine Encephalitis virus

Botulinum neurotoxins

2 March 2005

Examples of Regulated Select Agents


  • Ebola viruses

  • Herpes B virus

  • Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)

  • Conotoxins

  • Ricin

  • Saxitonxin

  • Tetrodotoxin

Implementation of biological registry requirements at unc

2 March 2005 Materials

Implementation of Biological Registry Requirements at UNC

  • Campuswide Select Agent survey

  • Via survey, 465 laboratory Principal Investigators asked to thoroughly review their stock and report if they possess a Select Agent or plan to do so

  • Door-to-door follow-up to ensure 100% response

  • EHS follow-up of affirmative responses to determine is the agent was exempt

New research compliance issues for biological and hazardous materials

2 March 2005 Materials

New research compliance issues for biological and hazardous materials

2 March 2005 Materials

What constitutes bona fide research

2 March 2005 Materials

What Constitutes Bona Fide Research?

SEC. 817 of the USA Patriot Act:(Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism)

“Whoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both.”

Welcome 42 cfr 73 requirements

2 March 2005 Materials

Welcome 42 CFR 73 Requirements

  • Background checks—Security Risk Assessments (SRA)—done by U.S. Attorney General rather than UNC

  • Reasonable exclusions for toxins

  • Largely performance-based: Entity writes the Safety and Security Plans

  • Not prescriptive for card access, video surveillance, etc.

  • Inventory quantities generally only apply to toxins.

Safety plans

2 March 2005 Materials

Safety Plans

  • Our Safety Plan is Chapter 20 of UNC’s Biological Safety Manual, “Select Agent Management.”

  • Our Manual references:

    • CDC/NIH’s Biosafety in Microbiological and Biomedical Laboratories

    • OSHA Laboratory Standard (29 CFR 1910.1450)

    • OSHA Hazard Communication Standard (29 CFR 1910.1200)

    • NIH Guidelines for Research Involving Recombinant DNA Molecules

73 11 b security plan requirements

2 March 2005 Materials

73.11(b) Security Plan Requirements

  • Physical security

  • Procedures for securing the area when no SRA-approved individual is present

  • Procedures for the loss or compromise of keys, passwords, combinations, etc.

  • Protocols for changing access following staff changes

  • Provisions for routine cleaning, maintenance, repairs, security training

Security costs for one building one 1 000 sq ft lab

2 March 2005 Materials

Security Costsfor one building, one <1,000 sq. ft. lab

Card system failures

Stolen cards Materials

Lost cards

Loaned cards

Are visitors issued cards? Is the card system used to record all area access?

Piggybacking/tailgating–following someone inside

Revolving door–entering upon someone’s exit

Blocking doors open

“Innocent” piggybacking—entry by multiple cardholders following a single swipe (no record of cardholders who don’t swipe)

2 March 2005

Card System Failures

Security training is required!

Security improvements

2 March 2005 Materials

Security Improvements


Typical Current



Typical Current

Federal Government


“When we have a free path, we go forward. If we meet an obstacle, we go around it. If the object cannot be overcome, we retreat. When the enemy is unprepared, we surprise him. If he is alert, we leave him alone.”—Baader-Meinhoff Gang, infamous German urban terrorist organization

73 11 b security plan requirements cont

2 March 2005 Materials

73.11(b) Security Plan Requirements, cont.

  • Procedures for reporting suspicious persons or activities, loss, theft or release, or alteration of inventory records

  • Procedures for reporting and removing unauthorized persons

  • Cyber security

  • Inventory control procedures

Select agent tracking system to account for all vials origin and destination

2 March 2005 Materials

Select Agent Tracking System“to account for all vials…origin and destination”

Physical inventory issues

2 March 2005 Materials

Physical Inventory Issues

  • 5,000 microcentrifuge tubes for one Principal Investigator

  • What’s inside? What can you see through the frost?

  • Annual joint EHS-PI physical inventories are incredibly time consuming

  • 5,001 microcentrifuge tubes?

  • 4,999 microcentrifuge tubes?

  • If a tube is missing, who took it? Inventory records probably won’t help.

Physical inventory issues1
Physical Inventory Issues Materials

  • Misplaced vials

  • Misrecorded information

  • It will happen!

Other typical steps for select agent security

2 March 2005 Materials

Other Typical Stepsfor Select Agent Security

  • EHS witnesses packing, unpacking and final destruction of Select Agents

  • Chain of custody for Select Agent receipt

  • Laboratory staff carry picture IDs

  • Visitors must sign logbook, wear temporary badges and be escorted at all times

  • EHS annually inspects lab to verify locations, staff and security and safety measures

Ehs access approval check off

2 March 2005 Materials

EHS Access Approval Check Off

  • Security Risk Assessment of individual

  • Individual’s Occupational Health compliance

  • EHS Training of individual

  • Operational lab engineering controls

  • Operational security system

  • Principal Investigator compliance

    • Current Laboratory Safety Plan

    • Training, occupational health, SRA compliance for all lab staff

    • Satisfactory inspection result

  • Institutional Biosafety Committee approval

Uses in clinical research
Uses in Clinical Research Materials

  • Products approved under the Federal Food, Drug and Cosmetic Act are exempt

  • Upon request, HHS may exempt investigational products on a case-by-case basis

Nih bioterrorism research funding

2 March 2005 Materials

NIH Bioterrorism Research Funding

  • President Bush proposed a 0.7% increase for NIH in FY 2006. Not since 1964 has NIH received an annual increase of less than 1%.

  • However, NIH’s National Institute of Allergy and Infectious Diseases, which funds most of its bioterrorism-related research, is once again the agency's biggest gainer at $4.5 billion, a 1.8% increase of $57 million.

  • Budgets for the Strategic National Stockpile and environmental biosurveillance—also related to bioterrorism—would also increase by 3.6% to $1.6 billion.

  • DHHS Secretary Mike Leavitt explained, "We have focused money on the most urgent priorities."

Controversial paper il4 mousepox

2 March 2005 Materials

Controversial Paper: IL4-Mousepox

Ronald J. Jackson and colleagues at Australia's Commonwealth Science and Industrial Research Organization and Australian National University

Journal of Virology, February 2001

In trying to develop a mouse contraceptive to control pest populations, the researchers inserted a gene for an immune-system molecule called interleukin-4 into the mousepox virus. Instead of rendering mice infertile, the engineered virus was far more deadly than the natural strain, killing even mice that had been vaccinated against mousepox.

Controversial paper synthetic polio virus

2 March 2005 Materials

Controversial Paper: Synthetic Polio Virus

Eckard Wimmer and researchers at the State University of New York at Stony Brook

Science, August 9, 2002 (online edition, July 11)

Used the genetic sequence of poliovirus to order pieces of DNA from a company. By patching the pieces together and putting the complete DNA chain into a soup of cellular molecules, the team created poliovirus particles capable of paralyzing and killing mice.

Nrc report on dual use research

2 March 2005 Materials

NRC Report on Dual Use Research

Report of the National Research Council of the National Academies:

“Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003)

Gerald Fink, Committee Chair

National science advisory board for biosecurity nsabb charge

2 March 2005 Materials

National Science Advisory Board for Biosecurity (NSABB) Charge

  • Develop and promulgate national guidelines for local (e.g. IBCs) and federal oversight of dual use research.

  • Develop a code of conduct for scientists and laboratory workers in life sciences research.

  • Develop and implement programs for education and training in biosecurity issues for all scientists and laboratory workers at federal as well as federally funded institutions.

  • Develop and promulgate guidelines for the appropriate communication of dual use research methodology and research results.

  • Foster the extension of these biosecurity policies to the international arena.

Experiments that currently require institutional biosafety committee ibc approval

2 March 2005 Materials

Experiments That Currently Require Institutional Biosafety Committee (IBC) Approval

  • Those using pathogens (biosafety level 2 and higher)

  • Cloning DNA from pathogens

  • Transfer of recombinant DNA material into whole animals;

  • Transgenic animal production;

  • Use of transgenic animals that come from other institutions;

  • Gene knockout animal experiments that involve transfer of foreign DNA into whole animals; and

  • Gene transfer experiments in humans.

New experiments of concern

2 March 2005 Materials

New Experiments of Concern

  • Would demonstrate how to render a vaccine ineffective

  • Would confer resistance to therapeutically useful antibiotics or antiviral agents

  • Would enhance the virulence of a pathogen or render a nonpathogen virulent

  • Would increase transmissibility of a pathogen

  • Would alter the host range of a pathogen

  • Would enable the evasion of diagnostic/detection modalities

  • Would enable the weaponization of a biological agent or toxin

New research compliance issues for biological and hazardous materials

Saturday, February 5, 2005 MaterialsBy Alice Dembner and Stephen Smith, The Boston Globe

BU Scientists Missed Bacteria-illness Link Chief Of Research On Tularemia Quits

Boston University scientists ran tests in August that showed two laboratory workers had been exposed to tularemia, but they did not connect the results to their illnesses three months earlier because they were convinced that they were working with a weakened strain of the bacteria that could not cause disease, BU officials said yesterday.

A top university administrator and the state's leading infectious disease official said that the test results should have

spurred the researchers to investigate more thoroughly. But it was not until two months later, weeks after a third worker fell ill, that the researchers determined that the bacteria they were working with were probably contaminated with the active, disease-causing form.

Also yesterday, BU said Dr. Peter Rice, who headed the campus's tularemia research, had resigned all his positions at the university and at Boston Medical Center. BU had placed him on leave and removed him as head of infectious diseases at BMC, saying he had allowed safety lapses in his lab. Rice has worked at BU for about 30 years.

Rice's lawyer said the infections were not caused by safety lapses, but "by the unknown presence of a virulent organism. in the lab.”

Medical surveillance for biosafety level 3 laboratories prior to laboratory work

2 March 2005 Materials

Medical Surveillance For Biosafety Level 3 Laboratoriesprior to laboratory work

  • Medical examination

  • Special consideration for immunocompromised individuals

  • Collection of baseline serum sample

  • Vaccination, if available.

  • Annual titer measurement.

  • Illness surveillance and management

  • Exposure reporting

U s nuclear regulatory commission

2 March 2005 Materials

U.S. Nuclear Regulatory Commission

  • Enhanced Security Measures for Certain Radioactive Materials Licensees

  • To be implemented in 2005

New research compliance issues for biological and hazardous materials

June 21, 2004 MaterialsBy JEFFRY SELINGOThe Chronicle of Higher Education

Settlement with EPA Will Cost Fitchburg State College $205,000

Boston Fitchburg State College will pay $50,000 in fines and spend $155,000 on two environmental projects as part of a settlement with the U.S. Environmental Protection Agency over hazardous-waste violations on its campus, in Massachusetts.

Last year the EPA proposed fining Fitchburg State $358,000 for improperly storing laboratory chemicals that could have exploded or released toxic vapors near two active classrooms. Inspectors

also found numerous containers of unknown materials and improperly marked wastes, some of which were stored unsafely. After the EPA inspection, some 6,500 pounds of hazardous wastes were shipped off the campus. Some of the material was so dangerous that crews had to use a robot to collect it.

"The problems at Fitchburg State College were severe and put students and staff at risk," Robert W. Varney, regional administrator for the EPA's New England office, said in a written statement on Friday.

Besides the fine, the college also agreed to have independent environmental audits of its facilities conducted annually for three years and to put in place a formal environmental…

Top rcra compliance problems satellite accumulation area

2 March 2005 Materials

Top RCRA Compliance ProblemsSatellite Accumulation Area

  • Unmarked or unlabeled containers

  • Open containers

  • Failure to make a hazardous waste determination

Satellite accumulation area solution number one remember the three l s

2 March 2005 Materials

Satellite Accumulation Area Solution Number One:Remember the ThreeL’s

  • Labels:“Hazardous Waste”

  • Lids

    • To prevent fugitive emissions

    • Funnels are for temporary use only

  • Location: at or near the point of generation

Storage without a permit solution number two promptly remove your waste

2 March 2005 Materials

Storage Without a Permit Solution Number Two:Promptly Remove Your Waste

  • Contract or standing order for hazardous waste disposal

  • Regularly scheduled shipments

  • Publicized waste collection procedure

  • Education of faculty and staff

Ehs role in research compliance at unc

2 March 2005 Materials

EHS’ Role in Research Compliance at UNC

  • EHS Radiation Safety Section

    • Receives, processes and delivers all orders for radioactive materials

  • EHS Industrial Hygiene and Biological Safety Section

    • OSHA Chemical Hygiene Officer

  • EHS Environmental Affairs Section

    • Hazardous waste pickup and management

  • EHS University Employee Occupational Health Clinic

New research compliance issues for biological and hazardous materials

2 March 2005 Materials

UNC Internal Processing FormQuestion: Does the proposal involve research with any of the following materials?

  • Radioactive Materials

  • Potential Biological Hazards (viruses, recombinant DNA, etc)

  • Chemical Hazards (poisons, explosives, reagents, flammables, carcinogens, etc)

  • This study involves the use of botulinum neurotoxins, botulinum neurotoxin producing species of clostridium or preparations or pharmaceuticals containing botulinum neurotoxins.

    If yes, contact EHS for required approvals.

New research compliance issues for biological and hazardous materials

2 March 2005 Materials

UNC Laboratory Safety PlanA Laboratory Safety Plan is required for all research in UNC laboratories

  • Schedule A: Laboratory Project Information

  • Schedule B: Hazardous Chemicals

  • Schedule C: Radioactive Materials

  • Schedule D: X-ray Equipment

  • Schedule E: Lasers

  • Schedule F: Biological Hazards

  • Schedule G: Recombinant DNA

  • Schedule H: Animals

Other laboratory safety plan approvals prior to the start of research at unc

2 March 2005 Materials

Other Laboratory Safety Plan Approvals Prior to the Start of Research at UNC

  • Schedule C: Radioactive Materials

    • University Radiation Safety Committee review and approval

  • Schedule F: Biological Hazards

    • Institutional Biosafety Committee (IBC) review and approval

    • BSL-3 Agent

    • New BSL-3 Laboratory

    • Select Agent

  • Schedule G: Recombinant DNA

    • Institutional Biosafety Committee (IBC) review and approval

Other ehs research approvals

2 March 2005 Materials

Other EHS Research Approvals

  • Certificate of Environmental Compliance

    • Only certain granting agencies

    • EHS will sign

  • Registration Of Human Gene Transfer Experiments

    • Co-approval by IBC and IRB

Personnel requirements for unc research

2 March 2005 Materials

Personnel Requirements for UNC Research


2 March 2005 Materials


Peter A. Reinhardt, Director

Department of Environment, Health & Safety

University of North Carolina

1120 Estes Drive Extension CB# 1650

Chapel Hill, NC 27517-4440